Roche ACCU-CHEK Inform II User manual

Accu-Chek

®

Inform II

BLOOD GLUCOSE MONITORING SYSTEM

Operator’s Manual

2 0 8938318001 (01) 2020-03 EN-CAN • Accu-Chek Inform II Operator’s Manual Version 4.1

Revision History

Manual content version Revision date Changes

Version 1.0 2008-01 New document, international launch with document

0 4807839001 (01) EN 2008-01.

Version 2.0 2009-08 Update, new SW version 02.00; creation document

versions 0 5956200001 (01) 2009-08 EN-CAN/

0 5956218001 (01) 2009-08 FR-CAN for Canada

Version 3.0 2010-09 Update, new SW version 03.00. This manual version

not available in Canada.

Version 4.0 2012-11 Update, new SW version 03.04 (OTS, OTE), revision

Cleaning/Disinfection section; misc. editorial revi-

sions; international launch with document

0 4807839001 (04) 2012-11 EN. This document not

available in Canada.

Version 4.0 2013-11 Creation documents 0 5956200001 (02) 2013-11

EN-CAN/ 0 5956218001 (02) 2013-11 FR-CAN

containing Canada-specific changes. Additionally,

implemented information on barcode symbologies;

misc. corrections/amendments to v4.0 international.

Version 4.1 2020-03 Update of complete manual to cover new features of

SW versions 03.05, 03.06 and 03.07. New material

number. Update of C&D information.

0 8938318001 (01) 2020-03 EN-CAN

Operator’s Manual

Version 4.1

A

CCU-

CCU-C

HEK

®

Inform II System

4 0 8938318001 (01) 2020-03 EN-CAN • Accu-Chek Inform II Operator’s Manual Version 4.1

The contents of this document, including all graphics, are the property of Roche Diagnostics. No part of this

document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any

purpose, without the express written permission of Roche Diagnostics. Roche Diagnostics has made every

reasonable effort to ensure that all the information contained in this manual is correct at the time of printing.

However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of

ongoing product development.

Please send questions or comments about this manual to your local Roche representative.

ACCU-CHEK, ACCU-CHEK INFORM, ACCU-CHEK PERFORMA and COBAS are trademarks of Roche.

All other trademarks are the property of their respective owners.

The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance.

0 8938318001 (01) 2020-03 EN-CAN • Accu-Chek Inform II Operator’s Manual Version 4.1 5

On the packaging, on the identification plate of the meter, the battery pack, the base unit, or the code key

reader you may encounter the following symbols, shown here with their meaning:

Caution, consult accompanying documents. Refer to safety-related notes in the instructions

for use accompanying this product.

Temperature limitation (Store at)

Manufacturer

Catalog number

In vitro diagnostic medical device

This product fulfills the requirements of the European Directives 98/79/EC on in vitro

diagnostic medical devices and 1999/5/EC on radio and telecommunications terminal

equipment (R&TTE).

This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada.

The compliance mark indicates that the product complies with the applicable standard and

establishes a traceable link between the equipment and the manufacturer, importer or their

agent responsible for compliance and for placing it on the Australian and New Zealand

market.

The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in accordance

with UL 61010-1 and CAN/CSA-C22.2 No. 61010-1)

Power supply connection (Base Unit, Base Unit Light: legacy version)

Power supply connection (Base Unit, Base Unit Light) or

Power supply connection (Base Unit, Base Unit Light)

IVD

7.5V 1.7A

12V 1.25

A

12V 1.50

A

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What is new in publication version 4.1?

This section provides an overview of all major changes

from Operator’s Manual version 4.0 to version 4.1. Dele-

tions or minor corrections are not listed.

SW 03.05 Description of new features SW 03.05 and amendments

from the supplement (English master document

0 7155271001 (02) 2014-10 EN and all derived transla-

tions) have been implemented.

■ The hourglass icon appears after the test strip has

been inserted to indicate that the meter is checking

the test strip. This new workflow applies whenever

you perform a test, whether patient glucose test,

control test, proficiency, or linearity. For an exam-

ple, see page 59.

■ With SW 03.05 the Accu-Chek Inform II meter soft-

ware supports more languages in the user inter-

face. Please contact your local Roche organization

for more information about the availablitly of lan-

guage packs.

SW 03.06 Communication via WLAN can be encrypted in the same

way as wired communication between base unit and

DMS. This option can only be configured via a DMS. See

page 168.

SW 03.07 Based on customer feedback, new features have been

added and existing ones improved.

■ Configurable QC lockout. See page 56.

■ Patient ID validation: check against length. See

section A.1 “Table of configuration options”. See

page 166.

■ The date of birth (DOB) can now be displayed on

patient glucose test screens. See page 58.

■ Separate QC and Patient comment settings. See

page 79.

■ In case of an automatic power-off, results will be

automatically flagged with a standard comment.

See page 22.

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■ Improvement of data privacy. Automatic deletion of

outdated patient data, see page 144.

■ Reworked displaying error codes (see page 149f):

– Replaced the numbers by letters.

– Removed codes in decision messages.

New layout safety messages The presentation of safety messages in this manual has

been updated throughout. See section 1.2 “Important

safety instructions and additional information”.

Test principle Description of the test principle used by the meter. See

page 17.

Patient Glucose Testing Additional information on obtaining a blood sample has

been added. See page 60.

Barcode handling Additional information on working with barcodes has

been added. See page 172.

Corrections

■ Technical data of meter and code key reader have

been updated, see section 12.1 “Technical data”.

■ WLAN security settings have been updated, see

section A.1 “Table of configuration options”.

Accu-Chek Inform II Base Unit ■ The Accu-Chek Inform II Base Unit and Base Unit

Light with new hardware and software

(REF 07671717190 and REF 08376824190) have

replaced the legacy versions (REF 05060290001 and

REF 05920353001), and are described in section1.6

“Overview of the Accu-Chek Inform II Base Unit”.

■ An overview of the legacy versions of Accu-Chek

Inform II Base Unit and Base Unit Light and the cor-

responding technical information have been moved

to Appendix E.

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9

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What is new in publication version 4.1? 6

SW 03.05................................................................................................................................................ 6

SW 03.06................................................................................................................................................ 6

SW 03.07................................................................................................................................................ 6

New layout safety messages.......................................................................................................... 7

Test principle ....................................................................................................................................... 7

Patient Glucose Testing ................................................................................................................... 7

Barcode handling............................................................................................................................... 7

Corrections ........................................................................................................................................... 7

Accu-Chek Inform II Base Unit..................................................................................................... 7

1 Introduction 15

1.1

Before you start......................................................................................................................................... 15

Intended use ...................................................................................................................................... 15

Important information regarding use ....................................................................................... 15

If you need help................................................................................................................................ 16

Note on the use of “base unit” in this manual...................................................................... 16

Note on illustrations in this manual .......................................................................................... 16

What can the system do for you? .............................................................................................. 17

Test principle ..................................................................................................................................... 17

1.2 Important safety instructions and additional information......................................................... 18

Important information regarding safety................................................................................... 19

Disposal of the system ................................................................................................................... 21

Product safety.................................................................................................................................... 21

General care....................................................................................................................................... 21

Accessory box ................................................................................................................................... 21

Meter .................................................................................................................................................... 22

Power off meter ................................................................................................................................ 22

Automatic power-off....................................................................................................................... 22

Battery Pack ....................................................................................................................................... 22

Touchscreen....................................................................................................................................... 24

Laser scanner .................................................................................................................................... 25

Electromagnetic compatibility (EMC)....................................................................................... 25

Electrostatic discharge (ESD)...................................................................................................... 26

Wireless connectivity (RF card) .................................................................................................. 26

Radiofrequency radiation exposure information.................................................................. 27

Local Area Network: protection from unauthorized access ............................................ 29

Wired network connection ........................................................................................................... 29

Note on systems with older hardware ..................................................................................... 31

1.3 System components................................................................................................................................ 33

1.4 Overview of the meter ............................................................................................................................ 35

1.5 Overview of the code key reader ....................................................................................................... 36

1.6 Overview of the Accu-Chek Inform II Base Unit .......................................................................... 37

1.7 Overview of the Accu-Chek Inform II Base Unit Hub................................................................. 39

1.8 Overview of the accessory box ........................................................................................................... 40

1.9 Reagents and consumables................................................................................................................. 40

1.10 Instructions for initial setup.................................................................................................................. 41

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2 Powering Up and Entering an Operator ID 43

2.1 Powering up the meter........................................................................................................................... 43

Adjusting the display ...................................................................................................................... 44

Adjusting the display on meters with older hardware ....................................................... 44

Enabling/disabling wireless connectivity (RF card) ............................................................ 45

Closing startup .................................................................................................................................. 46

2.2 Entering the operator ID........................................................................................................................ 46

Entering an operator ID with barcode scanner .................................................................... 47

Entering the operator ID manually............................................................................................. 48

Entering a password ....................................................................................................................... 48

3 Patient Glucose Testing 49

3.1

Information regarding blood glucose testing ................................................................................ 49

Preparing to test ............................................................................................................................... 49

3.2 Performing a patient glucose test...................................................................................................... 51

Overview of test procedure .......................................................................................................... 51

Entering or selecting the patient ID .......................................................................................... 51

Entering the patient ID manually................................................................................................ 53

Selecting the patient ID from a list............................................................................................ 54

Entering a patient ID with barcode scanner .......................................................................... 55

Confirming or selecting the test strip lot................................................................................. 56

Patient identification information............................................................................................... 58

Inserting test strips .......................................................................................................................... 59

Obtaining a blood sample............................................................................................................. 60

Applying a blood sample............................................................................................................... 61

Results screen ................................................................................................................................... 62

Adding comments............................................................................................................................ 65

Additional Patient Test ................................................................................................................... 67

4 Glucose Control Testing 69

4.1

Information regarding glucose control tests.................................................................................. 69

Glucose control testing intervals................................................................................................ 70

Information stored during glucose control testing.............................................................. 71

Control solutions............................................................................................................................... 71

Preparing to run a glucose control test ................................................................................... 71

4.2 Performing glucose control tests ....................................................................................................... 72

Overview of test procedure .......................................................................................................... 72

Starting a glucose control test .................................................................................................... 73

Confirming or selecting the lot number for control solutions ......................................... 74

Confirming or selecting the test strip lot................................................................................. 75

Inserting test strips .......................................................................................................................... 76

Applying the control solution....................................................................................................... 77

Results screen ................................................................................................................................... 78

Performing a STAT test .................................................................................................................. 80

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5 Review Results 81

5.1 Displaying test results from the memory ........................................................................................ 81

Information stored in data records for test results.............................................................. 81

List of results stored in the memory ......................................................................................... 81

6 Storing Test Strip, Control Solution, and Linearity Solution

Information in the Meter 83

6.1

Storing information about test strips................................................................................................ 83

Transferring code key information to the meter .................................................................. 84

Editing test strip data...................................................................................................................... 87

6.2 Storing control solution information ................................................................................................. 90

Entering the lot number of the control solution ................................................................... 90

Selecting a stored lot number as the current lot number ................................................ 93

6.3 Storing linearity test information........................................................................................................ 95

Entering the lot number of the linearity test.......................................................................... 95

Selecting a stored lot number as the current lot number ................................................ 97

7 Linearity Testing 99

7.1

Information regarding linearity tests................................................................................................. 99

Linearity testing intervals ........................................................................................................... 100

Information stored during linearity testing.......................................................................... 100

Linearity test kit ............................................................................................................................. 101

Preparing to run a linearity test ............................................................................................... 101

7.2 Performing a linearity test.................................................................................................................. 102

Overview of test procedure ....................................................................................................... 102

Starting a linearity test ................................................................................................................ 102

Confirming or selecting the lot number for linearity test kits....................................... 103

Confirming or selecting the test strip lot.............................................................................. 103

Inserting test strips....................................................................................................................... 104

Applying a linearity test sample .............................................................................................. 105

Results screen ................................................................................................................................ 106

8 Proficiency Testing 107

8.1

Information regarding proficiency tests ....................................................................................... 107

Information stored during proficiency testing.................................................................... 108

Preparing a proficiency test ...................................................................................................... 108

8.2 Performing a proficiency test............................................................................................................ 109

Overview of test procedure ....................................................................................................... 109

Starting a proficiency test.......................................................................................................... 109

Entering the proficiency sample ID........................................................................................ 110

Confirming or selecting the test strip lot.............................................................................. 110

Inserting test strips....................................................................................................................... 111

Applying a proficiency sample................................................................................................. 112

Results screen ................................................................................................................................ 113

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9 Initial Startup 115

9.1 Connecting the base unit .................................................................................................................. 115

9.2 Installing or replacing the battery pack ....................................................................................... 117

Removing the battery pack........................................................................................................ 118

Installing the battery pack ......................................................................................................... 119

9.3 Docking the meter ................................................................................................................................ 122

9.4 Setting the date and time................................................................................................................... 124

9.5 Beeper options ....................................................................................................................................... 125

10 Maintenance and Care 127

10.1

Conditions for storage and shipping ............................................................................................. 127

General operating conditions ................................................................................................... 127

Shipping............................................................................................................................................ 128

Storage .............................................................................................................................................. 129

10.2 Cleaning/disinfecting the Accu-Chek Inform II system.......................................................... 129

Guide to cleaning and disinfecting the Accu-Chek Inform II system ...................... 130

Difference between cleaning and disinfecting .................................................................. 130

When to clean/disinfect.............................................................................................................. 130

Approved cleaning and disinfecting products................................................................... 131

Technical Assistance ................................................................................................................... 132

What to clean/disinfect............................................................................................................... 133

How to clean/disinfect ................................................................................................................ 135

Cleaning the barcode scanner window................................................................................ 137

Cleaning/disinfecting the base unit ....................................................................................... 137

Cleaning/disinfecting the accessory box ............................................................................. 138

10.3 Logging maintenance activities....................................................................................................... 139

10.4 Diagnostics view.................................................................................................................................... 141

10.5 Deleting patient data ........................................................................................................................... 143

Manual deletion............................................................................................................................. 143

Automatic deletion........................................................................................................................ 144

11 Troubleshooting 145

Errors and unusual behavior without error messages

.................................................... 145

Pop-up messages.......................................................................................................................... 149

Meter reset ...................................................................................................................................... 151

12 General Product Information 153

12.1

Technical data ....................................................................................................................................... 153

12.2 Further Information............................................................................................................................... 157

Ordering ........................................................................................................................................... 157

Accu-Chek Inform II Operator’s Manual and Quick Reference Guide..................... 159

Reagents and Solutions.............................................................................................................. 159

Product limitations........................................................................................................................ 159

Warranty ........................................................................................................................................... 159

Information about software licenses...................................................................................... 160

Contact Roche................................................................................................................................ 160

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A Appendix 161

A.1 Table of configuration options ......................................................................................................... 161

A.2 Example of barcode symbologies ................................................................................................... 172

B Appendix 175

B.1

Option: Wireless network (WLAN) ................................................................................................. 175

Preliminary note............................................................................................................................. 175

Background..................................................................................................................................... 175

Technical implementation.......................................................................................................... 176

Location and type of RF card ................................................................................................... 177

RF specific functionalities and effective performance claims...................................... 178

C Supplement for Other Test Entry 181

C.1

Before you start...................................................................................................................................... 181

Description ...................................................................................................................................... 181

C.2 Overview of Other Test Entry (OTE) ............................................................................................... 182

Introduction..................................................................................................................................... 182

C.3 Recording Other Patient Tests ......................................................................................................... 185

C.4 Recording Other Control Tests ........................................................................................................ 192

Introduction..................................................................................................................................... 192

Other Control Testing Intervals................................................................................................ 192

Stored Control Information........................................................................................................ 192

Warning messages ....................................................................................................................... 198

C.5 Reviewing Other Test Results........................................................................................................... 199

C.6 Other Test Entry Configuration Options ....................................................................................... 202

D Supplement for Observed Test Sequence 203

Observed Test Sequence (OTS)

............................................................................................... 203

Using the OTS function............................................................................................................... 204

E Appendix for Accu-Chek Inform II Base Unit and Base Unit Light

(legacy versions) 207

E.1

Overview of the base unit with older hardware......................................................................... 207

E.2 Connecting the base unit (legacy version) ................................................................................ 209

E.3 Cleaning/disinfecting the base unit (legacy version).............................................................. 209

E.4 Technical data ....................................................................................................................................... 210

Index 211

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Introduction • 1

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1 Introduction

1.1 Before you start

Intended use The Accu-Chek

®

Inform II system is intended for in vitro

diagnostic use in the quantitative determination of blood

glucose levels in venous, capillary, arterial, and neonatal

whole blood samples for monitoring blood glucose. This

product is for monitoring hypoglycemia in neonates

diagnosed with laboratory glucose methods. The system

is indicated for use by healthcare professionals. For

healthcare professionals, the system is a bedside unit that

can help you provide quality patient care by measuring

blood glucose and by automating the record keeping

associated with blood glucose and glucose control tests.

Important information regarding

use

Read this operator's manual, as well as the package

inserts for all relevant consumables, before using the

system for the first test.

You must configure the Accu-Chek Inform II system

according to your needs before initial use. You can con-

figure the system by using a suitable data management

system. Refer to Appendix A for configuration via a data

management system. The device may not be used in

screening for neonatal hypoglycemia.

Be sure to read the “Important safety instructions and

additional information” section in this chapter before

operating the system.

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If you need help Information about using the system, the screen menus and

performing a test can be found in this operator's manual.

Error messages that appear on-screen include informa-

tion or instructions on how to correct the error.

For all questions about the Accu-Chek Inform II system

that are not answered in this manual, contact your Roche

representative (see Chapter 12). In order to expedite

troubleshooting, please have ready your Accu-Chek

Inform II meter, its serial number, this manual, and all

related consumables when you call. If you suspect a com-

munication error beyond the meter, also have your

Accu-Chek Inform II Base Unit serial number ready to

help assist our customer care group in troubleshooting.

Note on the use of “base unit” in

this manual

Note on illustrations in this

manual

Unless otherwise specified, the term “base unit” refers

to both the Accu-Chek Inform II Base Unit and the

Accu-Chek Inform II Base Unit Light.

Illustrations in this manual show two different kinds of

hands:

Hand without glove Hand with glove

A dashed arrow between screen illustrations indicates

that some screens have been skipped in these

illustrations.

Introduction • 1

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What can the system do for you? The Accu-Chek Inform II system has the following

features and properties:

■ Perform patient blood glucose tests and glucose

control tests with control solution.

■ Automatically record all relevant data for the appli-

cation, which includes:

– Time and date of test

– IDs for operator, patient, and samples

– Information about control solutions, test strips, and

linearity

– Test results and comments

■ Record patient test results, quality control test

results and reagent information for certain off-

meter manual tests.

■ For purposes of quality assurance, information on

the following areas can be collected, stored, and

transferred:

– Meters

– Test strips

– Glucose control solutions

– Linearity solutions

– Test results

Test principle An enzyme on the test strip converts the glucose in the

blood sample to gluconolactone. This reaction creates a

harmless DC electrical current that the meter interprets

and converts into a blood glucose result. The sample and

environmental conditions are also evaluated using AC

and DC signals.

For more details, refer to the test strip package insert.

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1.2 Important safety instructions and additional information

This section explains how safety-related messages and

information related to the proper handling of the system

are presented in the Accu-Chek Inform II manual. Please

read these passages carefully.

These symbols and signal words are used for specific

hazards:

The safety alert symbol alone (without a signal word)

promotes awareness to hazards which are generic or

directs the reader to related safety information.

WARNING

Indicates a hazardous situation which, if not avoided,

could result in death or serious injury.

CAUTION

Indicates a hazardous situation which, if not avoided,

could result in minor or moderate injury.

NOTICE

Indicates a hazardous situation which, if not avoided, may

result in damage to the system.

Important information that is not safety relevant is

presented against a colored background (without a

symbol). Here you will find additional information on

correct use of the meter or useful tips.

Introduction • 1

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Important information regarding

safety

Operator qualification

Only trained healthcare professionals may operate the

Accu-Chek Inform II system. Operators must also have

received comprehensive instruction in the operation,

quality control, and care of the Accu-Chek Inform II

system.

WARNING

Protection against infection and blood-borne

pathogens

Healthcare professionals using the Accu-Chek Inform II

system to perform tests must be aware that any object

coming into contact with human blood is a potential

source of infection. Operators need to adhere to Standard

Precautions when handling or using the Accu-Chek

Inform II system. All parts of this system should be

considered potentially infectious and are capable of

transmitting blood-borne pathogens between patients

and between patients and healthcare professionals.

■ Use gloves. Wear a new pair of clean gloves for test-

ing each patient.

■ Wash hands thoroughly with soap and water before

putting on a new pair of gloves and performing the

next patient test.

■ Use an auto-disabling single-use lancing device for

each patient.

■ Dispose of used lancets in a sturdy sharps container

with lid.

■ Dispose of used test strips from patient and

proficiency tests according to your institution’s infec-

tion control policy.

■ Follow all health and safety regulations in force

locally.

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CAUTION

Allergy or injury caused by reagents and other

working solutions

Direct contact with reagents, detergents, cleaning/disin-

fection solutions, or other working solutions may cause

skin irritation or inflammation.

■ Always use protective gloves.

■ Observe the cautions given in the package inserts of

the reagents and cleaning/disinfection solutions.

■ If a reagent, control, linearity, or cleaning/disinfection

solution comes into contact with your skin, wash it off

immediately with water.

■ Follow all health and safety regulations in force

locally.

WARNING

Avoidance of electrical shock, fire, and explosions

■ Only use Roche original accessories (cables, power

supply units, battery packs, and spare parts). Third-

party cables, power supply units, and battery packs

can cause the battery pack to explode or the meter to

become damaged.

■ Do not use loose power sockets or damaged power

supply units, cables, plugs, or battery packs.

■ Do not short circuit the power supply unit, the base

unit charging contacts, or the battery pack.

■ Do not drop the Accu-Chek Inform II meter, the power

supply unit, or the battery pack and protect these

against shaking and vibrations.

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